HIGH GOLD PALLADIUM FREE CERAMIC SOLDER

K012877 · Ivoclar USA, Inc. · EJT · Nov 21, 2001 · Dental

Device Facts

• Record ID: K012877
• Device Name: HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
• Applicant: Ivoclar USA, Inc.
• Product Code: EJT · Dental
• Decision Date: Nov 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3060
• Device Class: Class 2

Intended Use

Used for brazing dental alloys prior to porcelain application.

Device Story

High Gold Palladium Free Ceramic Solder is a dental material used by dental professionals for brazing dental alloys. The device facilitates the joining of metal components prior to the application of porcelain in restorative dentistry. It is intended for prescription use only.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

High gold, palladium-free ceramic solder for dental alloy brazing. Class II device (21 CFR 872.3060, Product Code EJT).

Indications for Use

Indicated for use in dental procedures requiring the brazing of dental alloys prior to the application of porcelain.

Regulatory Classification

Identification

A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized lines representing the wings or feathers.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 21 2001

Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar USA, Incorporated 175 Pineview Drive Amherst. New York 14150

Re: K012877

Trade/Device Name: High Gold Palladium Free Ceramic Solder Regulation Number: 872.3060 Regulation Name: Alloy For Procelain Fused To Metal Regulatory Class: II Product Code: EJT Dated: August 22, 2001 Received: August 27, 2001

Dear Mr. Gulati:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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## Page 2 - Mr. Gulati

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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______________________________________________________________________________________________________________________________________________________________________________

| 510(k) Number (if known): | Not yet assigned K012877 |
|---------------------------|--------------------------|
|---------------------------|--------------------------|

High Gold Palladium Free Ceramic Solder Device Name:

Indications For Use:

: 上一篇: :

Used for brazing dental alloys prior to porcelain application.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X (Per 21 CFR 801.109) |
|------------------|------------------------|
|------------------|------------------------|

OR

| Over-The-Counter Use | _ (Optional Format 1-2-96) |
|----------------------|----------------------------|
|----------------------|----------------------------|

| Division Sign-Off | |
|---------------------------------------------------------------------|--|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | |